The refund of 510(k) user fee

Ashley Fu

Starting to get Involved
According to FAQ 14 in the guidance "a User Fees and Refunds for Premarket Notification Submissions (510(k)s)" , If eligible,
we just need to submit a written request to the appropriate Center in FDA to request a refund no later than 180 days after the fee was due.

It seems the process of the refund is not complex. :applause:
But is there any information required in the written request? Does it need to explain the backgrounds specificly about the refund?

Did someone have successfully got the refundment from FDA?It's the first time I encounter the situation.


Any comments will be much appreciated!
 
Top Bottom